Approval to update the labeling for the healon5® ophthalmic viscosurgicaldevice (ovd) to remove the physician training program for new users and to revise the precautions section of the directions for use to allow for other ovd removal techniques.
| Device | SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5 |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2015-06-11 |
| Decision Date | 2015-08-25 |
| PMA | P810031 |
| Supplement | S054 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P810031 | | Original Filing |
| S072 |
2021-06-02 |
30-day Notice |
| S071 | | |
| S070 | | |
| S069 |
2020-11-27 |
30-day Notice |
| S068 |
2020-10-01 |
30-day Notice |
| S067 |
2020-04-29 |
30-day Notice |
| S066 | | |
| S065 |
2018-12-03 |
Normal 180 Day Track |
| S064 |
2018-02-02 |
30-day Notice |
| S063 |
2017-10-30 |
Normal 180 Day Track |
| S062 |
2017-06-26 |
30-day Notice |
| S061 |
2016-11-16 |
30-day Notice |
| S060 | | |
| S059 |
2016-11-14 |
Normal 180 Day Track No User Fee |
| S058 |
2016-08-01 |
Real-time Process |
| S057 |
2016-06-10 |
30-day Notice |
| S056 |
2015-12-17 |
Normal 180 Day Track |
| S055 |
2015-11-25 |
Special (immediate Track) |
| S054 |
2015-06-11 |
Normal 180 Day Track |
| S053 |
2015-06-03 |
30-day Notice |
| S052 |
2015-02-18 |
30-day Notice |
| S051 |
2014-08-29 |
30-day Notice |
| S050 |
2013-07-19 |
30-day Notice |
| S049 |
2013-07-01 |
30-day Notice |
| S048 |
2013-05-28 |
30-day Notice |
| S047 |
2013-03-15 |
30-day Notice |
| S046 |
2012-10-22 |
Real-time Process |
| S045 |
2012-07-02 |
30-day Notice |
| S044 |
2012-03-30 |
30-day Notice |
| S043 |
2012-01-17 |
30-day Notice |
| S042 |
2012-01-04 |
30-day Notice |
| S041 |
2011-10-07 |
30-day Notice |
| S040 |
2011-08-01 |
30-day Notice |
| S039 |
2011-06-23 |
30-day Notice |
| S038 |
2010-09-03 |
Normal 180 Day Track No User Fee |
| S037 |
2010-04-13 |
Real-time Process |
| S036 |
2008-08-20 |
30-day Notice |
| S035 |
2008-01-18 |
Normal 180 Day Track No User Fee |
| S034 |
2007-05-07 |
30-day Notice |
| S033 |
2006-12-11 |
135 Review Track For 30-day Notice |
| S032 |
2006-11-01 |
30-day Notice |
| S031 |
2006-09-29 |
Normal 180 Day Track No User Fee |
| S030 |
2006-08-14 |
30-day Notice |
| S029 |
2006-08-14 |
30-day Notice |
| S028 |
2006-08-14 |
30-day Notice |
| S027 |
2006-04-13 |
Real-time Process |
| S026 |
2005-02-08 |
30-day Notice |
| S025 |
2003-11-14 |
30-day Notice |
| S024 |
2002-07-10 |
Special (immediate Track) |
| S023 |
2000-05-12 |
Normal 180 Day Track |
| S022 |
1999-09-20 |
Normal 180 Day Track |
| S021 | | |
| S020 | | |
| S019 |
1994-10-07 |
Normal 180 Day Track |
| S018 |
1994-10-03 |
Normal 180 Day Track |
| S017 |
1994-02-23 |
Normal 180 Day Track |
| S016 | | |
| S015 | | |
| S014 |
1990-07-05 |
Normal 180 Day Track |
| S013 |
1989-04-24 |
Normal 180 Day Track |
| S012 |
1988-11-22 |
Normal 180 Day Track |
| S011 |
1988-06-01 |
Normal 180 Day Track |
| S010 |
1987-08-13 |
Normal 180 Day Track |
| S009 | | |
| S008 |
1986-06-03 |
Normal 180 Day Track |
| S007 |
1985-11-07 |
|
| S006 |
1984-09-17 |
|
| S005 |
1984-02-23 |
|
| S004 |
1984-02-10 |
|
| S003 | | |
| S002 |
1984-01-27 |
|
| S001 |
1983-08-31 |
|
NIH GUDID Devices